Stephen Bartlett – Drug Pricing Policy Watchhttp://www.drugpricingpolicywatch.com
Wed, 28 Feb 2018 17:06:02 +0000en-UShourly1https://wordpress.org/?v=4.9.9Massachusetts Senate Passes Bill Aiming to Increase Drug Price Transparency and Notification Obligationshttp://www.drugpricingpolicywatch.com/2018/01/22/massachusetts-senate-passes-bill-aiming-to-increase-drug-price-transparency-and-notification-obligations/
http://www.drugpricingpolicywatch.com/2018/01/22/massachusetts-senate-passes-bill-aiming-to-increase-drug-price-transparency-and-notification-obligations/#respondMon, 22 Jan 2018 15:39:57 +0000http://www.drugpricingpolicywatch.com/?p=143On October 17, 2017, the Massachusetts Senate Working Group on Health Care Cost and Containment and Reform (initially convened in the fall of 2016) released draft legislation entitled “An Act furthering Health Empowerment and Affordability by Leveraging Transformative Health Care.” The Massachusetts Senate engrossed the bill, with significant amendments, on November 11, 2017 (the “bill”). In addition to proposed changes in the regulation of hospitals and insurers operating within the state,… More]]>On October 17, 2017, the Massachusetts Senate Working Group on Health Care Cost and Containment and Reform (initially convened in the fall of 2016) released draft legislation entitled “An Act furthering Health Empowerment and Affordability by Leveraging Transformative Health Care.” The Massachusetts Senate engrossed the bill, with significant amendments, on November 11, 2017 (the “bill”). In addition to proposed changes in the regulation of hospitals and insurers operating within the state, the bill would impose significant drug price transparency and notification obligations on drug manufacturers, and subject drug manufacturers to the oversight of two state entities.

First, the bill requires drug manufacturers to provide early notice of certain pipeline drugs to the state’s Health Policy Commission. Manufacturers must provide such early notice for: 1) any pipeline drug; 2) any abbreviated new drug application for generic drugs; or 3) any biosimilar/biologics license application. Manufacturers must make this notice no later than 60 days after the receipt of FDA action date, or after submission of an ANDA application to FDA. For each prescription drug, notice to the Health Policy Commission shall include a brief description of the: 1) primary disease, health condition or therapeutic area being studied and the indication; 2) route of administration being studied; 3) clinical trial comparators; and 4) estimated year of market entry. For each pipeline drug, notice to the Health Policy Commission shall include a statement whether the drug has been designated by FDA as: 1) an orphan drug; 2) fast track; 3) a breakthrough therapy; 4) for accelerated approval; or 5) priority review for a new molecular entity.

Second, the bill authorizes the Health Policy Commission to assess fees on manufacturers for any increased expenses in connection with the commission’s review of these early notice submissions. The Health Policy Commission may also report any non-complying manufacturer to the Attorney General.

Third, the bill requires the state’s Center for Health Information and Analysis (“CHIA”) to promulgate regulations requiring drug manufacturers and PBMs to submit extensive product cost and pricing information for prescription drugs identified by CHIA including, but not limited to: 1) changes in WAC: 2) aggregate, company-level and product-specific research and development costs attributable to the specific drug; 3) the price paid by the manufacturer to acquire the prescription drug product if not developed by the manufacturer; 4) the 5-year history of any increases in WAC; 5) annual marketing and advertising expenses; and 6) a description of factors contributing to reported changes in WAC. CHIA must use this information to publish an annual report on drug manufacturer and PBM costs and cost trends.

Fourth, CHIA can fine drug manufacturers and PBMs for failure to timely submit drug pricing information. If, after notice from CHIA, a drug manufacturer or PBM does not submit the requested information within 2 weeks, CHIA can fine the manufacturer or PBM up to $5,000, and can continue assessing fines for each successive two-week period of delinquency up to $200,000.

Fifth, the bill authorizes CHIA to assess fees on drug manufacturers and PBMs for any increased expenses in connection with CHIA’s review of drug pricing information submissions. CHIA may also report any non-complying drug manufacturer or PBM to the Attorney General.

Sixth, the bill authorizes the Attorney General to investigate any organization referred to it by the Health Policy Commission or CHIA to determine whether the organization engaged in unfair methods of competition or anticompetitive behavior in violation of the state’s consumer protection laws.

This bill has engendered much debate in Massachusetts. We will be sure to keep you updated as drug price transparency legislation may now move through the House of Representatives.

]]>http://www.drugpricingpolicywatch.com/2018/01/22/massachusetts-senate-passes-bill-aiming-to-increase-drug-price-transparency-and-notification-obligations/feed/0Trade Organizations Challenge Nevada’s Drug Price Transparency Lawhttp://www.drugpricingpolicywatch.com/2017/09/19/trade-organizations-challenge-nevadas-drug-price-transparency-law/
http://www.drugpricingpolicywatch.com/2017/09/19/trade-organizations-challenge-nevadas-drug-price-transparency-law/#respondTue, 19 Sep 2017 14:11:15 +0000http://drugpricepolicywatch.foleyhoag.wpengine.com/?p=123We recently wrote about the newly enacted Nevada drug price transparency law here. The law requires manufacturers of prescription diabetes drugs to disclose certain drug cost information to the state Department of Health and Human Services (“Department”). In addition, the law imposes several unique reporting requirements on non-profit patient advocacy groups and pharmaceutical sales representatives. We expected that these reporting requirements would garner some attention and,… More]]>We recently wrote about the newly enacted Nevada drug price transparency law here. The law requires manufacturers of prescription diabetes drugs to disclose certain drug cost information to the state Department of Health and Human Services (“Department”). In addition, the law imposes several unique reporting requirements on non-profit patient advocacy groups and pharmaceutical sales representatives. We expected that these reporting requirements would garner some attention and, likely, some opposition. We were correct.

On September 1, 2017, PhRMA and BIO filed a complaint in the U.S. District Court for the District of Nevada challenging the new law. The complaint challenges the law on constitutional grounds and alleges that it is preempted by both federal patent and trade secret laws. The complaint also includes a takings claim and an interstate commerce interference claim. First, the complaint alleges that the Nevada law directly conflicts with the Hatch-Waxman Act which allows patent holders to exclude others from making, using or selling new inventions. Second, the complaint alleges that the Nevada law nullifies the trade secret protections afforded by the Defend Trade Secrets Act of 2016. Third, the complaint alleges that enforcement of the Nevada law constitutes a taking without just compensation because it deprives affected manufacturers of trade-secret protection for their confidential information. Fourth, and finally, the complaint alleges that the Nevada law violates the dormant Commerce Clause because the penalties it imposes relative to drugs sold in Nevada would in fact impact those prices nationwide. As initial relief, the plaintiffs seek an injunction prohibiting the Department from implementing or enforcing the law.

Indeed, the theme of the complaint is that the Nevada law undermines the federal mechanisms that incentivize pharmaceutical manufacturers to invest substantial money, time and effort into the development of critical diabetes drugs, and fails to acknowledge the risks associated with such innovative ventures. The complaint notes that although there have been substantial advances in diabetes drug treatments, new diabetes treatments and improving existing treatments require continuing research and, to that end, PhRMA’s and BIO’s members invest billions each year. Moreover, the compliant highlights the more recent preventative focus in diabetes research and development and explains that, despite recent advancements, “costly and labor-intensive research continues to lay the groundwork for the next generation of treatments.” The complaint alleges that, on average, a diabetes drug manufacturer spends between 10 and 15 years and $2.6 billion developing a new medicine with no guarantee of a return on any of these investments.

To date, the state of Nevada has not filed a responsive pleading. We will continue to keep you apprised of developments in this litigation.

First, the law requires nonprofit patient advocacy groups to annually compile a report disclosing any payment,… More

]]>Nevada Governor Brian Sandoval recently signed into law a drug price transparency bill, SB 539. The law primarily concerns price transparency measures for prescription diabetes drugs, but also imposes reporting requirements on nonprofit patient advocacy groups and pharmaceutical sales representatives that we’ve yet to see enacted in any other state.

First, the law requires nonprofit patient advocacy groups to annually compile a report disclosing any payment, donation, subsidy or anything of value received from a drug manufacturer, insurer, health benefit plan, participating public agency, pharmacy benefit manager or a trade group representing any of those entities during the preceding calendar year. The report must include: 1) the amount of each contribution; 2) the source of each contribution; and 3) the percentage of the advocacy group’s annual gross income attributable to such contributions. A patient advocacy group must either post the annual report on its website, or, if the group does not maintain a website, submit the report to the Department of Health and Human Services. The Department will then post the report on its website. If a patient advocacy group fails to comply with the law’s reporting requirements, the Department may impose a penalty of not more than $5,000 for each day of such failure.

Second, the law requires manufacturers of prescription drugs to provide to the Department a list of each pharmaceutical sales representative who markets prescription drugs on behalf of the manufacturer. Manufacturers must update the list at least annually. A person who is not included on a current list cannot market prescription drugs on behalf of the manufacturer. Each year, sales representatives must submit a report to the Department. This report must include a list of providers, pharmacies, medical facilities and persons licensed under the Nevada insurance code for whom the sales representative provided: 1) any compensation with a value that exceeds $10; or 2) total compensation with a value that exceeds $100 in the aggregate. The report must also include the name and manufacturer of each prescription drug for which the pharmaceutical sales representative provided a free sample. If a pharmaceutical sales representative fails to comply with the law’s reporting requirements, the Department may impose a penalty of not more than $500 for each day of such failure.

The Department will analyze the information submitted by pharmaceutical sales representatives on an annual basis and compile a report. The Department will then submit the report to the Governor and, in even-numbered years the legislature. This report must be compiled and disseminated so that it does not reveal the identity of any person or entity.

]]>http://www.drugpricingpolicywatch.com/2017/06/26/nevada-enacts-drug-price-transparency-law/feed/0Massachusetts Senator Introduces Drug Transparency Bill Vesting CHIA and Attorney General with Oversight Authorityhttp://www.drugpricingpolicywatch.com/2017/05/26/massachusetts-senator-introduces-drug-transparency-bill-vesting-chia-and-attorney-general-with-oversight-authority/
http://www.drugpricingpolicywatch.com/2017/05/26/massachusetts-senator-introduces-drug-transparency-bill-vesting-chia-and-attorney-general-with-oversight-authority/#respondFri, 26 May 2017 16:08:06 +0000http://drugpricepolicywatch.foleyhoag.staging.wpengine.com/?p=70On January 19, 2017, Senator Mark C. Montigny introduced S.652 – “An Act to promote transparency and cost control of pharmaceutical drug prices.” The bill currently sits in the Senate Committee on Health Care Financing, and covers the following categories of drugs: 1) the 10 costliest drugs to private payers in a given year; 2) the 10 drugs causing the highest annual increase in private payer spending;… More]]>On January 19, 2017, Senator Mark C. Montigny introduced S.652 – “An Act to promote transparency and cost control of pharmaceutical drug prices.” The bill currently sits in the Senate Committee on Health Care Financing, and covers the following categories of drugs: 1) the 10 costliest drugs to private payers in a given year; 2) the 10 drugs causing the highest annual increase in private payer spending; 3) drugs introduced into the US market in the past 10 years with a WAC of $10,000 or more annually or per course of treatment; and 4) drugs with a WAC increase of 50% over the past 5 years, or 15% within the past year.

Manufacturers of any covered drug must report to the Center for Health Information and Analysis (“CHIA”) on factors contributing to the drug’s cost or cost increase, including: 1) annual total cost of production; 2) R&D costs (including which entity paid them); 3) price paid by the manufacturer to acquire the drug if not developed in house; 4) annual marketing and advertising costs; and 5) average profit margin of the drug over the most recent 5-year period and the projected profit margin anticipated in the coming year. CHIA must publish an annual report on this, and can fine manufacturers for non-reporting. CHIA may also promulgate regulations requiring similar reporting from payers, providers, provider organizations, and PBMs and may fine those entities for non-reporting.

In terms of drug pricing oversight and enforcement, the bill empowers the Health Policy Commission, in consultation with CHIA and the data it collects, to annually identify drugs with costs that are “excessively higher than justified.” In turn, the bill would empower the MA AG to review and analyze the aggregated drug price information, and to demand that any provider, provider organization, payer, PBM or manufacturer produce documents, answer interrogatories and provide testimony under oath. Finally, the bill authorizes the MA AG to promulgate consumer protection regulations defining “excessively higher than justified” drug prices as an “unfair practice” subject to a consumer protection action.